NCT05032352

Predictive Assay for Decision Making in Adjuvant Therapy

Predictive Assay for Decision Making in Adjuvant Therapy (PADMA)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Insight Molecular Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor \< or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation

Detailed description

This is a prospective, non-randomized, 2 arm, multi-center study in patients with histologically documented non-squamous NSCLC who have undergone complete resection (R0) of the primary tumor with pathologically stage I or IIA disease. Routine paraffin-embedded tumor specimens from completely resected (R0) stage I or IIA patients with non-squamous NSCLC will undergo testing with the DetermaRx 14-Gene Prognostic Assay and will be designated as HIGH, INTERMEDIATE or LOW risk by the assay. The physician and patient will determine the best treatment course and will be assigned to treatment arm based on decision of adjuvant therapy or observation: 1. Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other. 2. Observation (Arm 2) All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first. All patients will be observed for disease free survival and overall survival to the end of study or death, whichever occurs first

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Adjuvant	Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other.
OTHER	Observation	All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.

Timeline

• Start date: 2022-01-28
• Primary completion: 2022-10-28
• Completion: 2022-10-28
• First posted: 2021-09-02
• Last updated: 2022-11-14

Locations

18 sites across 1 country: United States